Pharmacokinetics and bioequivalence study of the two 20-MG quinapril hydrochloride tablet formulations in healthy Thai male volunteers

Journal of the Medical Association of Thailand

Volumn 91, Issue 5, 2008, Pages 739-746

  Rojanasthien, Noppamas ^a   Nasangiam, Nayada ^a   Kumsorn, Boonyium ^a   Roongapinun, Sukit ^a   Jengjareon, Apiwat ^a  

^a Faculty of Medicine Chiang Mai University   (Thailand)

Author keywords

Bioequivalence; Pharmacokinetics; Quinapril

Indexed keywords

QUINAPRIL; QUINAPRILAT; QUINARIL;

ADULT; AMPLIFIER; ANALYSIS OF VARIANCE; ANALYTIC METHOD; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIET RESTRICTION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG HALF LIFE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; MALE; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; PHARMACOKINETICS; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; TABLET FORMULATION; THAILAND; TIME TO MAXIMUM PLASMA CONCENTRATION; ULTRAVIOLET RADIATION; VOLUNTEER;

ADULT; ANALYSIS OF VARIANCE; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; ANTIHYPERTENSIVE AGENTS; AREA UNDER CURVE; CROSS-OVER STUDIES; HUMAN EXPERIMENTATION; HUMANS; LINEAR MODELS; MALE; TABLETS; TETRAHYDROISOQUINOLINES; THAILAND; THERAPEUTIC EQUIVALENCY;

EID: 44649146524     PISSN: 01252208     EISSN: 01252208     Source Type: Journal    
DOI: None     Document Type: Article

References (12)

1. th ed. New York: McGraw-Hill; 2006: 789-821.
2. Olson SC, Horvath AM, Michniewicz BM, Sedman AJ, Colburn WA, Welling PG. The clinical pharmacokinetics of quinapril. Angiology 1989; 40: 351-9.
3. Culy CR, Jarvis B. Quinapril: a further update of its pharmacology and therapeutic use in cardiovascular disorders. Drugs 2002; 62: 339-85.
4. Plosker GL, Sorkin EM. Quinapril. A reappraisal of its pharmacology and therapeutic efficacy in cardiovascular disorders. Drugs 1994; 48: 227-52.
5. Wadworth AN, Brogden RN. Quinapril. A review of its pharmacological properties, and therapeutic efficacy in cardiovascular disorders. Drugs 1991; 41: 378-99.
6. Cetnarowski-Cropp AB. Quinapril: a new second-generation ACE inhibitor. DICP 1991; 25: 499-504.
7. Criteria and guideline for the bioequivalence study of generic drugs. Nonthaburi: Drug Control Division, Food and Drug Administration Thailand, Ministry of Public Health; 2000.
8. Abbara C, Aymard G, Hinh S, Diquet B. Simultaneous determination of quinapril and its active metabolite quinaprilat in human plasma using high-performance liquid chromatography with ultraviolet detection. J Chromatogr B Analyt Technol Biomed Life Sci 2002; 766: 199-207.
9. Heinzel G, Wolosczak R, Thomann P. TopFit version 2.0: pharmacokinetic and pharmacodynamic data analysis system. Stuttgart: Gustav Fischer Verlag; 1993.
10. Nation RL, Sansom LN. Bioequivalence requirements for generic products. Pharmacol Ther 1994; 62: 41-55.
11. Sauter R, Steinijans VW, Diletti E, Bohm A, Schulz HU. Presentation of results from bioequivalence studies. Int J Clin Pharmacol Ther Toxicol 1992; 30(Suppl 1): S7-30.
12. Diletti E, Hauschke D, Steinijans VW. Sample size determination for bioequivalence assessment by means of confidence intervals. Int J Clin Pharmacol Ther Toxicol 1991; 29: 1-8.